ACETAMINOPHEN
- Product NDC
- 37835-512
- 11-digit product format
- 378350512
- Labeler code
- 37835
- Product ID
- 37835-512_30d44923-02f8-c4ea-e063-6294a90a935a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bi-Mart
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2019-04-18
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ACETAMINOPHEN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 1148399 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 37835-512-01 | ACETAMINOPHEN | 100 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 100 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 37835-512 | ACETAMINOPHEN TABLET, EXTENDED RELEASE [BI-MART] | 1 | Current NDC, 1 package rows | 20250323_ab2f0834-bdef-4862-b549-5a8161f8420b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 37835-512-01 | 37835051201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (37835-512-01) | 2025-03-01 | No | No | Current |